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In the pipeline:
Rivaroxaban tamps down action of a key player in blood clotting, called Factor Xa. Last month, the New England Journal of Medicine published two studies of more than 7,000 knee and hip replacement recipients who received either a daily rivaroxaban pill or today's standard injections. Pill users were less likely to suffer fatal and nonfatal vein clots. Bleeding and other side effects were similar with both drugs.
Johnson & Johnson, which is developing rivaroxaban with Bayer Healthcare AG, plans to seek Food and Drug Administration approval later this summer.
Pradaxa, or dabigatran, interferes with another blood clotting agent, called thrombin. European regulators cited research showing Pradaxa was as effective as standard shots in protecting orthopedic patients. Duke's Becker cautions that one U.S. study didn't show as big an effect; other research is continuing. This drug works similarly to the ill-fated Exantra, but Becker says there are no signs of liver toxicity so far.
Bristol-Myers Squibb's apixaban works against the same clotting factor as rivaroxaban; its key studies are under way.
Orthopedic surgery is an easier hurdle -- because vein clots are quick and common -- than proving if these pills will work as well as warfarin for people who need longer-term care. Stay tuned: Large studies comparing warfarin to each have begun at hospitals nationwide.
If they work, their targeted action promises fewer side effects, dietary restrictions or dose problems than warfarin, Fanikos notes. But warfarin still will play an important role, he cautions -- since the generic form sells for as little as $40 for a three-month supply.
To find enrolling studies: http://www.clinicaltrials.gov/
Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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